Microbiome Disease Clinical Trial Analysis: Key Insights into Rich Pipeline Featuring 140+ Companies and 180+ Therapies | DelveInsight
The potential of the microbiome in disease treatment and prevention is an emerging and highly promising field in medicine. Research into microbiome-based therapies, such as probiotics, prebiotics, and fecal microbiota transplants (FMT), is paving the way for novel treatments. By targeting the microbiome, scientists aim to restore or enhance microbial diversity, which could potentially prevent or treat these diseases, offering a more personalized and holistic approach to healthcare.
New York, USA, March 04, 2025 (GLOBE NEWSWIRE) — Microbiome Disease Clinical Trial Analysis: Key Insights into Rich Pipeline Featuring 140+ Companies and 180+ Therapies | DelveInsight
The potential of the microbiome in disease treatment and prevention is an emerging and highly promising field in medicine. Research into microbiome-based therapies, such as probiotics, prebiotics, and fecal microbiota transplants (FMT), is paving the way for novel treatments. By targeting the microbiome, scientists aim to restore or enhance microbial diversity, which could potentially prevent or treat these diseases, offering a more personalized and holistic approach to healthcare.
DelveInsight’s ‘Microbiome Disease Pipeline Insight 2025‘ report provides comprehensive global coverage of pipeline microbiome disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the microbiome disease pipeline domain.
Key Takeaways from the Microbiome Disease Pipeline Report
- DelveInsight’s microbiome disease pipeline report depicts a robust space with 140+ active players working to develop 180+ pipeline microbiome disease drugs.
- Key microbiome disease companies such as MaaT Pharma, Qu Biologics, Biomica Ltd., Seres Therapeutics, Micro Viable Therapeutics, Metagen Therapeutics, Inc, Microbiotica, Enterome, Azitra, Vedanta Biosciences, Inc, and others are evaluating new microbiome disease drugs to improve the treatment landscape.
- Promising pipeline microbiome disease therapies such as MaaT 013, QBKPN, BMC128, SER-155, MVT-201, MaaT03X, MGT-001, MGT-007, MB097, MB310, EO2463, ATR-12, ATR-04, VE202, VE303, VE707, and others are under different phases of microbiome disease clinical trials.
- In February 2025, Microbiotica shared new findings on the mechanism of action of MB097 at the American Association for Cancer Research (AACR) Immuno-Oncology meeting in Los Angeles, held from February 23-26. MB097, a live biotherapeutic product (LBP), is being developed as a complementary treatment for immuno-oncology therapies, including MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).
- In January 2025, MaaT Pharma released topline results from ARES, a crucial European Phase 3 study conducted across multiple centers. This single-arm, open-label trial assessed the efficacy and safety of MaaT013 in patients with acute Graft-versus-Host Disease (GI-aGvHD) affecting the gastrointestinal tract. The study focused on third-line treatment for patients who were resistant to steroids and either refractory or intolerant to ruxolitinib.
- In January 2025, PureTech Health plc reported that its Founded Entity, Vedanta Biosciences, has published new findings from the Phase 2 CONSORTIUM study on its lead candidate, VE303, which is being assessed for preventing recurrent Clostridioides difficile infection (rCDI).
- In January 2025, Seres Therapeutics, Inc. revealed new translational biomarker findings for exploratory endpoints from its Phase 1b placebo-controlled SER-155 study in patients undergoing allogeneic stem cell transplantation (allo-HSCT).
- In May 2024, Biomica Ltd. shared promising early results from its ongoing Phase 1 clinical trial. The study evaluates the safety and tolerability of BMC128, a microbiome-based immuno-oncology candidate, in combination with nivolumab, an anti-PD1 immune checkpoint inhibitor, for patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC).
Request a sample and discover the recent advances in microbiome disease drugs @ Microbiome Disease Pipeline Report
The microbiome disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage microbiome disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the microbiome disease clinical trial landscape.
Microbiome Disease Overview
The microbiome, the vast community of microorganisms residing in the human body, plays a crucial role in maintaining health. Disruptions to this delicate ecosystem, known as dysbiosis, have been linked to a wide range of diseases. Conditions such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), obesity, diabetes, and even neurological disorders like depression and Alzheimer’s disease have been associated with microbiome imbalances.
The gut microbiota, in particular, is essential for digestion, immune regulation, and the production of essential metabolites. When the balance of beneficial and harmful bacteria shifts, it can lead to chronic inflammation, immune dysfunction, and metabolic disorders.
Microbiome-related diseases are influenced by various factors, including diet, antibiotics, lifestyle, and genetics. For example, excessive antibiotic use can wipe out beneficial bacteria, allowing harmful pathogens to thrive. Similarly, a Western diet high in processed foods and low in fiber can reduce microbial diversity, promoting gut inflammation and metabolic dysfunction.
Recent research has focused on microbiome-based therapies, such as probiotics, prebiotics, fecal microbiota transplantation (FMT), and microbiome-targeted drugs, to restore balance and treat diseases. Understanding the complex interplay between microbes and human health offers new opportunities for preventing and managing microbiome-associated diseases, paving the way for personalized medicine approaches.
Find out more about microbiome disease drugs @ Microbiome Disease Analysis
A snapshot of the Pipeline Microbiome Disease Drugs mentioned in the report:
| Drugs | Company | Phase | Indication | RoA |
| MaaT 013 | MaaT Pharma | III | Graft-versus-host disease | Rectal (enema) |
| VE303 | Vedanta Biosciences | III | Clostridium difficile infections | Oral |
| QBKPN | Qu Biologics | II | Immunodeficiency disorders; Non-small cell lung cancer | SC |
| VE202 | Vedanta Biosciences | II | Inflammatory bowel diseases; Ulcerative colitis | Oral |
| BMC128 | Biomica Ltd. | I | Malignant melanoma; Non-small cell lung cancer; Renal cell carcinoma | Oral |
| SER-155 | Seres Therapeutics | I | Bacteraemia; Enterocolitis; Graft-versus-host disease; Intra-abdominal infections | Oral |
| ATR-12 | Azitra | I | Netherton Syndrome | Topical |
| MB097 | Microbiotica | I | Malignant melanoma | Oral |
Learn more about the emerging microbiome disease therapies @ Microbiome Disease Clinical Trials
Microbiome Disease Therapeutics Assessment
The microbiome disease pipeline report proffers an integral view of the emerging microbiome disease therapies segmented by stage, product type, molecule type, and route of administration.
Scope of the Microbiome Disease Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Intravenous, Subcutaneous, Oral, Intramuscular
- Therapeutics Assessment By Molecule Type: Monoclonal antibody, Small molecule, Peptide
- Key Microbiome Disease Companies: MaaT Pharma, Qu Biologics, Biomica Ltd., Seres Therapeutics, Micro Viable Therapeutics, Metagen Therapeutics, Inc, Microbiotica, Enterome, Azitra, Vedanta Biosciences, Inc, and others.
- Key Microbiome Disease Pipeline Therapies: MaaT 013, QBKPN, BMC128, SER-155, MVT-201, MaaT03X, MGT-001, MGT-007, MB097, MB310, EO2463, ATR-12, ATR-04, VE202, VE303, VE707, and others.
Dive deep into rich insights for new microbiome disease treatments, visit @ Microbiome Disease Drugs
Table of Contents
| 1. | Microbiome Disease Pipeline Report Introduction |
| 2. | Microbiome Disease Pipeline Report Executive Summary |
| 3. | Microbiome Disease Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Microbiome Disease Clinical Trial Therapeutics |
| 6. | Microbiome Disease Pipeline: Late-Stage Products (Pre-registration) |
| 7. | Microbiome Disease Pipeline: Late-Stage Products (Phase III) |
| 8. | Microbiome Disease Pipeline: Mid-Stage Products (Phase II) |
| 9. | Microbiome Disease Pipeline: Early-Stage Products (Phase I) |
| 10. | Microbiome Disease Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Microbiome Disease Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Microbiome Disease Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the microbiome disease pipeline therapeutics, reach out @ Microbiome Disease Therapeutics
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